Fecal continence is the ability to defer defecation until an appropriate time at an appropriate place. Fecal incontinence is the inability to defer defecation, commonly present in the elderly, spinal cord or head injury patients and other disabled persons, and in persons having other generalized diseases or abnormalities of the rectum or perineum. For a thorough summary of diagnoses of fecal incontinence by type of disease and area of dysfunction, see Schiller, "Fecal Incontinence" in Gastrointestinal Disease, (Fourth Ed., 1989), pg. 323.
There are many degrees of fecal incontinence, from complete lack of control of defecation, even with solid stool, to continuous dribbling of liquid stool in persistent and long standing diarrhea, to even occasional, intermittent slight soiling of clothing associated with acute attacks of diarrhea. At present, management of complete fecal incontinence consists principally of keeping the patient in diapers. The passage of stool is identified by the patient, if mentally competent enough to recognize it, who then informs an attendant. Otherwise, the odor of the stool in the vicinity of the patient or the regular visual check of the diaper are the usual means of learning that stool has been passed by the patient.
This practice, however, is extremely troublesome and unhealthy because even though solid or semi-formed stool can be captured fairly effectively by a diaper, stool frequently is squashed forward and backward between the buttocks and then onto and around the external genitalia and down the legs of the patient. Diarrheal (liquid) stool may leak or flow outside the diaper and onto the bed, and up the back of the patient and down along the legs. An even further problem is presented when a patient is seriously impaired mentally, in that he or she may reach down inside the diaper, grasp the stool, and smear it onto the rest of the body, including regions such as face and hair, or onto the bed before such practice is discovered.
It is clear that problems associated with the diaper system of managing fecally incontinent patients are substantial in a number of ways. For instance, the clean-up alone associated with such incidents requires a complete bath for the patient, a complete change of bed linens and clothing, and a complete cleaning of the bed frame which may be contaminated with stool not readily visible. Further, the inevitable spread of fecal contamination by a diaper may cause infection of the skin of the perineum, external genitalia, buttocks, legs, arms, head and lower trunk of the patient, and may contribute to the creation and persistence of decubitus ulcers or bed or pressure sores. Extensive bathing and re-bathing of the patient, changes of bed linen and the patient's clothing, and procedures necessary to combat the spread of infection are all extremely expensive both in terms of health care worker's time and hospital supplies.
The problem of incontinence is one that has far reaching effects on society in general as well. Fecal incontinence is often the major factor in the decision to institutionalize an elderly or otherwise impaired family member. Often, these patients require two to three times the amount of nursing care that similar but continent patients need. It is estimated that the care of institutionalized incontinent patients in the United States alone costs approximately eight billion dollars per year. In England, the prevalence of fecal incontinence in the general population has been estimated to be as high as 0.4 percent in general, and between 1.0 and 1.3 percent in the elderly population (i.e., those over 65 years old). In other studies, as many as fifty percent of institutionalized patients were observed to have fecal incontinence. Clearly, the problem of institutionalizing incontinent family members will be alleviated if a method were found that could allow the incontinent patient to be treated simply and effectively at home.
The one major method most commonly used at present in dealing with this problem, the diapering of patients, is not really treatment, but is an attempt to minimize the problem by capturing the stool when it is expelled from the rectum. As indicated above, this method is totally unsatisfactory. However, other methods used presently to treat incontinence have not been satisfactory either.
One non-specific strategy that has been used comprises keeping the colon and the rectum empty of feces by stimulating defecation at regular intervals by use of enemas and/or digital stimulation of the anus and rectum. Unfortunately, present nursing and medical practice texts list only small volume enemas, commonly administered in the left lateral decubitus position. As a result, this procedure will clean only the rectum, sigmoid, and a portion of the descending colon, as has been pointed out in my previous patent, U.S. Pat. No. 4,403,982, incorporated herein by reference.
The stimulation of defecation at regular intervals using conventional enema procedures does not cleanse the entire colon at all. After a routine less-than-a-liter enema administered with the patient lying in the left side-down decubitus position, residual stool is often still present in the cecum, ascending colon, transverse colon and descending colon even after defecation following this type of enema. This prior art method thus does not completely empty the entire colon of feces, gas and liquids. As a result, residual matter can remain in the cecum, or ascending or transverse segments of the colon, which then moves distally and can be expelled at any place and time by the incontinent patient.
Still another alternative treatment currently in use is the administration of anti-diarrheal drugs and a low residue bland diet which are used to arrest diarrhea. Although these methods are useful in reducing the expulsion of liquid stool from the colon, they present a serious risk of causing the development of fecal impactions in the colon, which if located too high can only be reached with a flexible colonoscope. Flexible colonoscopy requires sedation or anesthesia, and these procedures carry their own further risks. Additionally, diagnosis of high impactions, located proximal to the rectum, if often difficult, and may result in dangerous impactions not being diagnosed promptly. Thus anti-diarrheal drug treatment alone, at present, is unsatisfactory as a method of controlling the problem of fecal incontinence.
It is clear that the conventional methods most commonly used at present have failed to provide a safe, effective, inexpensive and sanitary method for dealing with the widespread problem of fecal incontinence which affects patients having a variety of conditions. It is thus highly desirable to develop a system for managing fecally incontinent patients which can be effective in reducing the many medical and economic problems associated with this condition. Additionally, it is desirable to have a system which will have low risk of harmful side effects, which will afford significant therapeutic benefits to the patient and to society, and which will allow for safer, more effective, and less expensive management of the functions of the colon in a great number of afflicted patients.